the purpose of this study is to assess clinical efficacy and safety of berovenal® intended to promote treatment and to expedite chronic diabetic foot ulcer healing

Conditions: Diabetic Foot Ulcer

Summary: the goal of this clinical investigation is to evaluate clinical efficacy of medical device berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. it will also learn about the safety of medical device berovenal®. the main questions it aims to answer are: * does medical device berovenal® lower the size of diabetic foot ulcer? * what medical problems do participants have when using medical device berovenal®? researchers will compare medical device berovenal® to a reference device (device with similar purpose of use). participants will: * use medical device berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed * visit the clinic once every 2 weeks for checkups and tests * keep a diary of their symptoms and the number of times they use medical device berovenal® or a reference device


Eligibility criteria:
inclusion criteria: * male, or female subjects aged 18-85 years; * diabetes mellitus (type 1 or 2) documented at least 12 months prior to visit 1; * presence of a diabetic foot ulcer meeting the following criteria (index ulcer): * grade 1 or 2 according to the wagner classification; * if applicable, surgically debrided ≥ 7 days prior to visit 1; * at the time of randomisation: * sized 1 - 25 cm2; * present for ≥ 14 days; * offloaded for ≥ 7 days; * not infected. * hba1c ≤ 10% (dcct) or 85.8 mmol/mol (ifcc) at visit 1; * willing and able to comply with the scheduled procedures; * legally capable, able to understand the provided information and willing to sign the informed consent form. exclusion criteria: * known contraindication for application of hydrogel dressings, incl. berovenal® and nu-gel hydrogel with alginate; * at the time of randomisation - documented reduction in index ulcer area by \> 20%, as compared to its size at visit 1; * index ulcer primarily caused by a medical condition other than diabetes mellitus; * inadequate arterial circulation to the foot documented within 28 days prior to visit 1, or during the screening period: * ankle-brachial index \ 1.3 and/or * toe-brachial index \< 0.7; * presence of acute charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to visit 1; * use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to visit 1, or documented intention to use them during the subject's participation; * use of any investigational drug(s) or device(s), systemic immunosuppressive treatment (including systemic corticosteroids), or application of topical steroids to the index ulcer surface, within 28 days prior to visit 1; * use of cytotoxic chemotherapy and/or radiotherapy within 6 months prior to visit 1; * known history of bone cancer or metastatic disease of the affected limb; * poor nutritional status; * presence of an on-going uncontrolled renal, hepatic, cardiovascular or other disease that could pose an additional risk for the participant, or could significantly influence interpretation of the results (as evaluated by the investigator); * known history of non-compliance and/or presence of any condition(s) seriously compromising the subject's ability to adhere to the procedures required by this clinical investigational plan; * pregnant or breast-feeding females; * females of childbearing potential not using an effective method of contraception.